The invention relates to a process for the production of pancreatin pellets, the pancreatin pellets produced by the process and medicines containing such pellets.
Pharmaceutical pellets are prepared mainly by two different techniques. In one technique utilizing suitable process apparatus (for example, pelletizing disks, fluidized beds or coating drums) a more or less spherical particle shape is built up from so-called seed grains by means of the alternating application of liquid and solid substances to the rolling or swirling seed grain. This is sometimes referred to as buildup granulation. In the other technique, the active ingredient is applied to the surface of prepared sugar globules.
Neither of these standard methods are particularly applicable to the production of pancreatin pellets. In buildup granulation, very large volumes of a liquid phase, consisting of water and/or various solvents are needed to build up the pellets. Water cannot be used in the production of pancreatin pellets because of the extreme sensitivity to humidity of the pancreas enzyme. Most of the other solvents utilized in building granulation are also more or less harmful to the enzyme. If a solvent that is harmless to the enzyme, such as isopropanol or acetone is applied, volumes which are multiples of the mass of the pellets are needed for their preparation; this is generally uneconomical and raises problems with respect to the emmission protection regulations. Frequently, pellets produced in this manner lack mechanical stability.
By the second method usually only relatively slight amounts of the active ingredient may be applied to the surface of the sugar globules exposed. This is possible only with the use of relatively large volumes of a liquid phase. Because, however, pancreatin preparations must be administered in single doses in considerable excess of 200 mg, this method is again not suitable for the preparation of pancreatin pellets.